Patients’ symptom experiences before and after lung cancer surgery -predictors of patients’ symptom burden

Trine Oksholm Doctoral thesis Faculty of medicine, University of Oslo, Norway 2016

Akuttklinikken og Lungeavdelingen- Rikshospitalet, OUS

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Acknowledgements When I think back on the work associated with my doctoral thesis I think of it as a journey. This feeling is supported by the fact that during these four years, I lived in three different cities and have had my workplace in five different research communities. When I started my work, I thought that this journey was one that I was going to do by myself. However, I soon discovered that you need assistance from a lot of people to complete such a research project. I am so lucky to have met a lot of nice people along the road and want to thank all of you. Luckily, I did not do this doctoral journey all by myself. My main supervisor Professor Tone Rustøen was by my side all the time. I want to thank her so much for all her professional input and support. In addition, I had support from my cosupervisor, a pulmonary physician, Professor Johny Kongerud. Another important person in the research group was thoracic surgeon, Dr. Steinar Solberg This study would not been possible without the participation of all of the patients who shared their experiences with me. I would like to express my gratitude to every patient who participated. My journey as a nurse started at the pulmonary division at Rikshospitalet – Oslo University Hospital (OUH). I want to thank all the nurses, physicians, and other personnel in the pulmonary division for all the support they gave to my work over several years. I especially want to thank Head Nurse Aina Presthus who gave me time off to apply for funding for my dissertation research and facilitated my job responsibilities so that I could complete my research. When I started this research project, I was working at the Centre for Shared Decision Making and Collaborative Care Research (CSDM) at OUH. At the beginning of the study, a lot of administrative work needed to be done. I want to thank the staff for all of their help through this process, especially PhD students Liv Wensaas and Kristin Hofsø who went through this same process before me. When I was working at CSDM, the recruitment of patients for this study began. The recruitment was done at four different locations. I want to thank the nurses and physicians who facilitated this recruitment. I addition, I want to thank Cathrine Berg, Camilla Knudsen, and Solveig Meier Myklebust who participated in the recruitment at the pulmonary division at Rikshospitalet-OUH, and Jeanette Orholt Lillesø and Annette Pedersen who did the same at the patient hotel at Ullevål – OUH. I want to thank Torhild Skarsvaag, Janne Landro Nilsen, Britt Elisabeth Nervik, Kari Hanne Gjeilo, and the other nurses who did the patient recruitment at St. Olav University Hospital. Lastly, I want to thank Line Lærum, Kari Henriksen, and the other nurses who did the patient recruitment at Haukeland University Hospital.

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The next place I worked was the Division of Emergencies and Critical Care, Ullevål –OUH. I transferred there together with my main supervisor. The new research group provided a warm welcome. I want to thank all of them for all of the interesting professional discussions and support. I especially want to thank Turid Hauge and Hanne B. Alfheim who continued to mail and record questionnaires when I was abroad. The next stop on my journey was San Francisco. The Norwegian Cancer Society awarded me a scholarship abroad. I spent seven months at the School of Nursing at University of California in San Francisco (UCSF). Professor Christine Miaskowski made this a great experience and taught me more than I thought was possible in such a short period of time. I am really grateful for this experience. She didn’t only work with me in USA, but follow me during all 4 years. I want to thank the statisticians, Drs. Bruce Cooper and Steven Paul who, both in class and during the data analyses, patiently explained all of the statistical methods to me. Other individuals who made this stay a great experience was my roommate Ellen Kristvik and Debby and Marshall who I shared an office with at UCSF. Back in Norway, I moved to my hometown of Bergen. I am grateful to Monica Nortvedt who provided me with an office at Centre for Evidence-based Practice at Bergen University College. In addition, Professor Nortvedt and her colleges included me into their research community. The last stop on my journey is Haraldsplass Deaconess University College. I want to thank principal and Professor Anne Kari Hersvik Aarstad and program coordinator Margareth Haukom, who gave me time off to complete my doctoral work. I want to thank my new colleges for all of their support during these last four months. In addition to all the professional help, my family and friends provided invaluable support during this work. My parents and brother have always supported me and believed that I could do anything I wanted to do. In addition, my two children supported me and reminded me of the importance of doing other things than working. Friends at different locations have encouraged me to not give up and gave me all kinds of practical help (e.g., a place to sleep, when I was living in the wrong city). Finally, I want to thank the Norwegian Cancer Society who funded my study. I want to thank the research committee who prioritized this study and everyone who participated in fund raising and gave donations that made this study possible.

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Summary

The purpose of this study was to explore multiple symptoms in lung cancer patients before and after surgery and to identify predictors of patients’ symptom burden (including age). In total, 264 lung cancer patients were recruited from 3 university hospitals. They completed questionnaires preoperatively, and 1 and 5 months after surgery. The study revealed that patients’ experienced a mean of 10 symptoms before surgery, with only small differences in the older patients compared to the younger ones (>65 years). When comparing the occurrence of symptoms before and after surgery, there was a significant increase in the mean number of symptoms at 1 month. However, the only characteristic that was associated with a higher number of symptoms 1 month after surgery was the number of symptoms reported before surgery. At 5 months, the number of symptoms was reduced compared to the 1 month assessment, but it was still significantly higher compared to the preoperative assessment. A total of 79% of the patients experienced shortness of breath (SOB) 5 months after surgery, while 71% experienced lack of energy, and 56% reported pain. Some of the symptoms were intense. Our findings show that patients with more comorbidities and a higher number of preoperative symptoms need special attention, as they tend to experience a higher number of postoperative symptoms. Even though it is recommended in guidelines, only 32% of the patients had physical therapy after surgery and 16% had inpatient rehabilitation. While 30% of the patients were working preoperatively, only 9% worked at 5 months. This study provides important information about the symptom burden of patients that underwent lung cancer surgery, and about the most vulnerable patients. The results can be used to educate patients about the normal course of postoperative recovery. Clinicians need to perform a comprehensive symptom assessment prior to surgery and at regular intervals after surgery.

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List of papers

Article 1: Oksholm, T., Miaskowski, C., Kongerud, J. S., Cooper, B., Paul, S. M., Laerum, L., Rustoen, T. (2013). Does age influence the symptom experience of lung cancer patients prior to surgery? Lung Cancer, 82 (1), 156-161. (Reproduced with permission from Elsevier Ireland Ltd. Copyright © 2013. All rights reserved.)

Article 2: Oksholm, T., Miaskowski, C., Solberg, S., Lie, I., Cooper, B., Paul, S. M., Kongerud, J., Rustoen, T. (2014). Changes in symptom occurrence and severity before and after lung cancer surgery. Cancer Nursing. 38(5):351-357, September/October 2015. (Reproduced with permission from Wolters Kluwer Health. Copyright © 2014. All rights reserved.)

Article 3: Oksholm, T., Rustoen, T., Cooper, B., Paul, S. M., Solberg, S., Henriksen, K., Kongerud, J., Miaskowski, C. Trajectories of symptom occurrence and severity from before through five months after lung cancer surgery. Journal of Pain and Symptom Management, 49 (6), 995-1015. (Reproduced with permission from Elsevier Ireland Ltd. Copyright © 2013. All rights reserved.)

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Abbreviations CTX

Chemotherapy

EORTC- QOL Quality of life questionnaire developed by the European Organization for Research and Treatment of Cancer FEV1

Forced expiratory volume in 1 second

FVC

Forced vital capacity

LC13

A disease specific module of the EORTC QOL questionnaire that assesses lung cancer specific symptoms

MSAS

Memorial Symptom Assessment Scale

NSCLC

Non-small cell lung cancer

PORT

Postoperative adjuvant radiotherapy

pTNM

A system for cancer staging based on tumor (T), node (N), and metastasis (M), when the staging is done by pathologist, normally after surgery

QOL

Quality of life

SCQ

Self-administered Comorbidity Questionnaire

SOB

Shortness of breath

TNM

A system for cancer staging based on tumor (T), node (N), and metastasis (M)

TSM

Theory of Symptom Management

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8

Page Acknowledgements Summary List of papers Abbreviations

3 5 6 7

1.0

INTRODUCTION

11

2.0

BACKGROUND 2.1 Lung cancer 2.2 Treatment of lung cancer 2.2.1 Surgery 2.2.2 Adjuvant chemotherapy (CTX) 2.2.3 Postoperative adjuvant radiotherapy (PORT) 2.3 Definition of a symptom and symptom experience of oncology patients 2.4 Symptoms in lung cancer patients before and after surgery 2.5 Symptoms influence on rehabilitation 2.6 Comorbidities effect on symptoms 2.7 Summary and critique of previous research on symptoms in patients undergoing surgery for lung cancer 2.8 Theory of Symptom Management (TSM)

15 15 17 18 19 20

3.0

AIMS

31

4.0

METHODS 4.1 Patients and settings 4.1.1 Inclusion criteria 4.2 Study procedures 4.3 Study Variables and Instruments 4.3.1 Demographic and clinical characteristics 4.3.2 Comorbidity Questionnaire 4.3.3 Symptoms assessment scale 4.3.4 Quality of life questionnaire 4.4 Statistics Paper 1 Paper 2 Paper 3 Supplementary analyzes 4.5 1.1 Ethical considerations

32 32 33 33 34 35 36 37 39 40 41 42 43 43 44

5.0

RESULTS 5.1 Sample 5.2 Results paper 1 5.3 Results paper 2

47 47 50 51 9

21 22 24 26 27 27

5.4 Results paper 3 5.5 Results of the additional analyses

51 53

6.0 DISCUSSION 6.1 Methodological considerations 6.1.1 Sample 6.1.2 Recruitment of patients 6.1.3 Data collection 6.1.4 Design and statistical analyses 6.1.5 Reliability and validity 6.2 General discussion 6.2.1 Symptoms at the different assessments 6.2.1.1. Preoperative symptoms 6.2.1.2 Symptoms at 1 month 6.2.1.3 Symptoms at 5 months 6.1.4 Summary of the symptoms 6.2.2 Demographic and clinical characteristics influencing symptom burden 6.2.2.1 Age 6.2.2.2 Comorbid conditions and preoperative symptoms 6.2.2.3 Gender 6.2.2.4 Adjuvant chemotherapy (CTX) 6.2.3 Consequences and treatment of a high symptom burden 6.3 Theory of Symptom Management (TSM)

57 57 57 58 60 61 65 67 69 69 70 71 75

7.0 CONCLUSIONS AND CLINICAL IMPLICATIONS

86

8.0 FUTURE RESEARCH

88

9.0 REFERENCES

89

APPENDIX Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6

Case Report Form (CRF) Inclusion procedure Informed consent Shortened enrollment questionnaires Information letter Information brochure

ARTICLE 1 ARTICLE 2 ARTICLE 3 10

75 76 78 79 79 80 82

1.0 INTRODUCTION Lung cancer is an important cause of morbidity and mortality across the world. It is a leading cause of cancer deaths (1, 2). Surgical resection is considered the treatment of choice for patients with early stage, non-small cell lung cancer (2). Lung cancer patients are normally diagnosed shortly before surgery and the operation is extensive. After 7 to 10 days, patients are discharged to their homes. Transitioning from one care setting to another is a risky part of patient care (3, 4). The transfer increases the risk for medications errors, discontinuity in patients’ followup visits, and worsening of symptoms (5-7). Both preoperatively and before discharge from the hospital, patients want information about the usual course of recovery of their physical and mental health (8, 9). However, limited information is available on lung cancer patients’ specific preferences following surgical treatment. In one study that presented hypothetical scenarios to 64 patients to assess their preferences for information following lung surgery (8), patients wanted information about postoperative outcomes (e.g., need for nursing home placement, oxygen dependence, restrictions in mobility, limitations in activities of daily living) before surgery to help them decide whether or not they want to have the surgery (8). At hospital discharge, patients need information about common symptoms and when to seek care for unrelieved symptoms (9). Patients often experience several symptoms simultaneously. The co-occurrence of multiple symptoms is reported to be associated with significant decreases in functional status and quality of life (QOL) (10). In addition to the occurrence of the symptom, its frequency, severity, and associated distress are described to influence the patient’s symptom experience (11). 11

Therefore, it is assumed to be of importance to assess more than the occurrence of the symptom to capture the symptom experience. The idea and inspiration for the study came from results of a previous study at Oslo University Hospital (OUH). In that study, data were collected using semistructured qualitative interviews with 11 patients, 3 months after lung cancer surgery (12). The patients described a postoperative period characterized by discomfort and lack of support from clinicians. They expressed a need for information about the normal postoperative period and when to contact a clinician (12). However, there is limited research about these patients rehabilitation phase. At the initiation of this dissertations research, a literature review was done. The literature search focused on patients who underwent surgery for lung cancer, because patients who are not offered surgery are described to experience different symptoms (13-15). A significant gap in the literature on patients’ symptoms and predictors of symptoms before and after lung cancer surgery was identified. Only four studies had evaluated symptoms in lung cancer patients prior to and after surgery (14, 16-18). In addition, only one study evaluated the severity and predictors of six symptoms at 1 and 4 months after lung cancer surgery (19). Although the previous studies provided interesting information, several limitations were noted. First, these studies evaluated a limited number of symptoms (14, 16-19) , mainly because their main focus was to assess QOL (16-18). In addition, these evaluations were limited to either ratings of symptom severity (16-19) or symptom distress (14). Only two of the previous studies reported predictors of patients’ symptom burden (14, 19). Assessment of predictors of patients’ symptom burden is important for identifying vulnerable groups of patients. The literature review 12

revealed a need for a more comprehensive study that assed multiple symptoms and predictors of these symptoms; evaluated multiple dimensions of symptoms (i.e., occurrence of, frequency, severity, distress), in a larger sample patients, from prior to and following lung cancer surgery. Lung cancer is a disease of the elderly (20). Older lung cancer patients have a higher number of comorbid conditions (21) and a higher number of comorbid conditions is associated with that patients report an increase the number of symptoms (14, 18). This study was conducted to gain knowledge about the symptom burden of elderly lung cancer patients from before through 5 months after surgery. Based on previous studies (15, 22, 23)SDWLHQWVLQWKLVVWXG\ZKRZHUH•\HDUVRI age were categorized as older. Due to the limited information about symptoms in lung cancer patients who undergo surgery and for comparative purposes, both older and younger patients were included in this study. Since in the first paper, few differences were found in the majority of symptoms between the two age groups; age was not the main theme in the other two papers. The Theory of Symptom Management (TSM) was chosen as the theoretical framework for this study, because it can be used as a guide to understand the patient’s symptom experience, particularly in terms of the multiple dimensions of symptoms (10). The three essential dimensions of the TSM are symptom experience, symptom management strategies, and symptom status outcomes. Due to the lack of evidence about surgically treated lung cancer patients’ symptoms, the main focus of the study was on patients’ symptom experience. Symptom experience is defined as a simultaneous perception, evaluation, and response to a change in one’s usual feeling (10). Knowledge about a patient’s symptom experience is necessary to develop and 13

test interventions to improve patients’ symptom management (10, 24, 25) and to change patients’ symptom status outcomes.

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2.0 BACKGROUND 2.1 Lung cancer More than 600.000 patients are diagnosed with lung cancer in the United States and Europe annually (26, 27). In Norway, at the time of this study in 2011, 2842 patients were diagnosed with lung cancer and 57% of them were men and 43% women (28). As the incidence of lung cancer increases, especially in women, the social and economic burden of this disease increases as well (29, 30). Factors like occupational and environmental exposures and genetic characteristics are risk factors for the development of lung cancer (31, 32). However, smoking is the main cause of lung cancer. Approximately 10% to 20% of smokers develop lung cancer (32). The duration of smoking, the number of cigarettes smoked per day, and the age when smoking was initiated are some of the determinants associated with this risk factor. Lung cancer is difficult to detect because in the early stages of the disease patients are often asymptomatic (32). As a result, patients diagnosed with lung cancer often have regional or distant spread at the time of diagnosis. Cancer statistics from the United States report that only 15.3% of lung cancer patients are diagnosed with localized disease (i.e., cancer found only in the part of the body where it started) (33). Lung cancer is broadly categorized into small cell lung cancer (SCLC) and non–small cell cancer (NSCLC), based on histological differences in the tumor cells. NSCLC accounts for 80% of the cases while SCLC makes up 20% (31). NSCLC is further divided into three major and several minor histologic classes. The major histologic classes are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma (34). NSCLC is staged based on the TNM system (i.e., tumor (T), node 15

(N), and metastasis (M)). SCLC is not TNM staged but divided into limited or extensive disease (35). The TNM classification system is used to stage the extent of NSCLC lung cancer. The T category describes the size and extent of the primary tumor; the N category describes the extent of involvement of regional lymph nodes; while the M category describes the presence or absence of distant metastasis (36). The TNM classification provides an indication of prognosis and aids clinicians in treatment planning (31). Based on the combinations of TNM staging, NSCLC is divided into stages from 0 – IV (i.e. Stage 0, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IV). While the staging system was revised in 2010, Stage 0 indicates no evidence of primary tumor and Stage IV indicates the presence of metastatic spread (31). Lung cancer is the most frequent cause of cancer deaths in Europe (26). In Norway in 2011, the 5 year survival rates for lung cancer patients were 12.1% for men and 16.8% for women (28). The survival rates for patients with early stage lung cancer (both NSCLC and SCLC) have improved over the past 25 years, due to improved surgical procedures, better patient selection and follow-up, and the use of adjuvant chemotherapy (CTX) (37-39). The 5 year survival rates for NSCLC depend on both the time of diagnose (stage of the disease) and sex (40-42). Based on the literature (40-42), the 5 year survival rates for women and men with different stages of disease are summarized in Table 1.

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Table 1 Five year survival rates for women and men with different stages of lung cancer

Gender

Stage I

Stage II

Stage III

Women

47 – 69 %

41 – 63 %

15 – 46 %

Men

33 – 64 %

32 – 52 %

6 – 37 %

Lung cancer appears to be a more aggressive disease in men compared to women at the same stage of the disease. In SCLC, 60–70% of the patients have extensive disease at the time of diagnosis (43). These patients have median survival of 7–12 months and the proportion alive at 5 years is approximately 2%. Among patients with limited-stage disease, median survival is about 23 months and 5 years survival is approximately 12–17% (43). 2.2 Treatment of lung cancer Surgical resection, radiotherapy, and CTX are the main curative treatments for NSCLC and SCLC. The specific treatment depends on the stage of the cancer, histology of the tumor, patients’ preferences, and patients’ physical condition (31). In previous years, single treatments were used. Currently, these patients receive a combination of treatments (31). The treatments for NSCLC and SCLC differ. SCLC is treated primarily with CTX or CTX combined with radiotherapy (35). Surgery is offered to only 5% of patients with SCLC who are diagnosed in very early stages of the disease (35, 44). In NSCLC, surgical resection is offered to patients with stage I, II, and IIIA cancer (2). In addition to surgery, patients with NSCLC are offered treatment with CTX or 17

radiotherapy. Adjuvant treatment is given before and/or after surgery, depending of the stage of the disease (37, 45-47). Because comorbidity increases with increasing age, the choice of optimal treatment for older patients with lung cancer can be challenging (48). The inability to predict which elderly patients are “fit” for treatment often results in under treatment (23, 48). The likelihood of receiving any kind of treatment for NSCLC decreases significantly with age (49). Older patients with lung cancer are less likely to be offered surgery (22, 50, 51), even though long term survival rates for older and younger patients are comparable (50, 52). Recently, recommendations about how to make treatment decisions seems to be based less on patients’ chronological age and more on the estimated absolute benefits of treatment, life expectancy, treatment tolerance, cognition, presence of comorbidities, and patient preferences (49). 2.2.1 Surgery As discussed above, surgery is the main treatment for NSCLC. This approach is used unless the preoperative assessment reveals dissociated disease or the primary lesion is inoperable (2, 35, 44). Historically, open thoracotomy was the only surgical approach for resection of tumor, lung tissue, and lymph nodes (31). During the last two decades, minimally invasive access - Video-Assisted Thoracic Surgery (VATS) has become more widespread. An increasing percentage of the patients are operated on using this method which is less traumatic and seems to offer the same survival advantage as open thoracotomy (53). The extent of resection performed during each operation is dependent mainly on tumor size and localization. Other factors include pre-exiting lung disease and the occurrence of comorbidities. Therefore, the extent of surgery 18

can vary from a wedge resection, segmentectomy, (bi-) lobectomy, to removal of the entire lung (pneumonectomy). In addition, reconstruction of airways and blood vessels can be performed in order to reduce the amount of lung tissue that needs to be removed. While removal of lymph nodes does not appear to improve survival (54), guidelines recommend that quite extensive dissection and removal of lymph nodes should be performed during these operations (54). If the surgeon determines that the tumor is too extensive to remove during surgery, the incision will be closed without tumor removal; which is referred to as exploratory surgery (55, 56). 2.2.2 Adjuvant chemotherapy (CTX) Patients are offered CTX before (neoadjuvant) or/and after (adjuvant) surgery depending of the stage of their disease (37, 45-47). Because only four of the patients who participated in this study received neoadjuvant CTX (i.e. treatment before surgery), the focus of this section is on adjuvant CTX. Adjuvant CTX is recommended after surgery for patients with more advanced cancer (57). In general, the majority of patients with stage II or III NSCLC benefit from adjuvant CTX. However, evidence about its benefit in patients with stage 1B is inconclusive (57, 58). The Norwegian guidelines (i.e., Nasjonalt handlingsprogram med retningslinjer for diagnostikk, behandling og oppfølging av lungekreft) recommend adjuvant CTX for stage II or III NSCLC (44), but not for stage 1B. Adjuvant CTX is usually started 4 to 6 weeks after surgery (57). The Norwegian guidelines recommend that treatment be initiated within 8 weeks (44). Vinorelbine with cisplatin is the most common adjuvant CTX regimen for lung cancer (57, 58). Usually, the treatment is given over 4 cycles. On day 1, patients receive a combination of vinorelbine with cisplatin, then a supplementary dose of vinorelbine 19

on day 8. This cycle is repeated every 21 days. The total duration of adjuvant CTX treatment is usually 10 weeks. Not every patient is able to complete all 4 cycles of CTX due to the toxic effects of the CTX. In some studies, only 50% of patients were able to complete all 4 cycles at the planned doses (57, 58). Treatment with CTX can increase symptoms and decrease QOL (57, 58). The most frequent toxic effects of adjuvant CTX for NSCLC are neutropenia, anemia, and febrile neutropenia (58). Other common side effects are asthenia (i.e., weakness), nausea, vomiting, anorexia, and infection (57, 58). 2.2.3 Postoperative adjuvant radiotherapy (PORT) Postoperative adjuvant radiotherapy (PORT) is recommended after adjuvant CTX for patients with resected NSCLC who have cancer cells present in two lymph nodes (i.e., N2 disease) and disease at Stage III A with N1 – N2 to reduce local recurrence (59). If the patient has N0 / pN1 disease, PORT is recommended if there is a suspicion of residual cancer (44). PORT is not recommended after pneumonectomy. Treatment with PORT is normally given 25 to 30 times (44). No studies were found that explored symptom burden in patients treated with surgery and PORT, respectively (60). However, usual side effects of PORT are dermatitis, esophagitis, gastrointestinal symptoms, and neurologic toxic reactions (60). An increased risk of death from non-cancer causes has occurred after PORT. However, the toxicity has decreased with improvements in planning and in treatment technology (60). Both the severe disease and its treatments can cause symptoms in lung cancer patients(61)

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2.3 Definition of a symptom and symptom experience of oncology patients A symptom and patients’ symptoms experiences are defined and described in different ways (11). In this study, we have chosen to define a symptom, as defined in the TMS, as a subjective experience that reflects changes in the biopsychosocial functioning, sensation, or cognition of an individual (62). In contrast, a sign is defined as any abnormality indicative of disease that is detectable by the individual or others (62). Both signs and symptoms are important aspects of health and illness. However, a symptom is the patient’s own subjective experience and cannot be measured by others. Knowledge about symptoms is important for cancer patients for several reasons. Symptoms are the most common reason why patients seek healthcare (10). Unrelieved symptoms are associated with increased psychological distress, decreased physical functioning, and reduced QOL (14). Symptoms can be produced by the disease itself, by treatments for the disease, from comorbid medical conditions, or from acute injuries (61). Each symptom is a multidimensional experience (11). In addition to the occurrence of the symptom, its frequency, severity, and associated distress can influence the patient’s symptom experience (11). The multidimensionality of the symptom experience is important because patients evaluate their symptoms, not only by their occurrence, but by making judgements about the severity, cause, treatability, and effects of symptoms on their lives (62). Previous research reports that the most prevalent symptoms are not necessarily the most severe or distressing (63, 64). Symptom distress is defined as the degree or amount of physical or mental upset, anguish, or suffering that in associated with a specific symptom (65). 21

Symptoms can be measured either individually or in combination with other symptoms (11). However, patients rarely experience a single symptom. Often, they experience multiple symptoms simultaneously (66). For example, patients with cancer were found to experience an average of 11 symptoms (67). The risk of experiencing multiple, concurrent symptoms after lung cancer surgery are high, since these patients can have both cancer-related symptoms as well as symptoms associated with surgery. The co-occurrence of multiple symptoms has a significant impact on patients’ level of functioning (61). Further research is warranted to examine the experience of multiple symptoms in these patients. 2.4 Symptoms in lung cancer patients before and after surgery To our knowledge, only five studies have evaluated changes in symptom occurrence, severity, and distress before and after lung cancer surgery (14, 16-19). All of these studies were published before the present study. Four of these studies reported symptoms preoperatively (14, 16-18), and one reported only symptoms after surgery (19). The most common preoperative symptoms were: cough, pain, dyspnea, loss of appetite, fatigue, and insomnia. One month after surgery, the most frequently reported symptoms were: fatigue, nausea, vomiting, insomnia, pain, and dyspnea (14, 16-19). The occurrence rates for all of these symptoms increased significantly after surgery. However, findings regarding the occurrence rates for the symptom at 4 to 6 months after surgery were inconsistent. While one study reported that the symptom rates at 4 to 6 months after surgery were back to preoperative levels (18), others reported that patients still experienced high rates of pain, dyspnea, fatigue, and cough at 4 to 6 months (14, 16, 17, 19) . All five studies used a longitudinal design, were well executed, and had a response rate of approximately 80% during 22

the first 4-6 moths (14, 16-19). A higher response rate is preferable because the missing data occurs at random (68). In addition, a response rate of approximate 80% is acceptable response rate for this patient population. Across these five studies, three different questionnaires were used to assess patients’ symptoms. Three of studies assed symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the EORTC QLQ-LC13 lung cancer-specific questionnaire (16-18). One study used the Symptom Distress Scale (SDS) (14) and the other study used the Lung Cancer Symptom Scale (LCSS) (19). While all three questionnaires have acceptable psychometric properties, the major purpose of the EORTC QLQ questionnaires is to measure patients’ QOL and not symptoms. While these five studies provided interesting information, several limitations warrant considerations. For three of the previous studies the main focus was to assess QOL (16-18). These studies reported data on a limited number of symptoms and restricted the findings to only occurrence or severity rates for this limited number of symptoms (16-18). The first study of 110 patients reported on the severity of only two symptoms, namely cough and dyspnea (18). The second study had a limited sample (i.e. 60) and a very limited age range (i.e., only patients between 70 and 80 years) (16). Small sample sizes reduce the studies statistical power; which reduces the chance of detecting a true effect, as well as reduces the likelihood that a statistically significant result reflects a true effect (68). In addition, the restricted age range of the second study, limits the generalizability of the study findings. In the third study (n=173), patients were divided into two groups; namely one that remained disease free at 2 years and one with patients with recurrent cancer diagnosed during follow-up (18). Although, this division is an interesting one, it is difficult to use the 23

results to inform patients about symptoms, because it is difficult to know who will have recurrent cancer several years after cancer surgery. In the last two of the five studies (14, 19); the primary focus was on an evaluation of patients’ symptoms. However, one study focused on symptom distress in lung cancer patients who received different treatments (i.e., surgery, CTX, radiotherapy). Of note, the surgery group in this sample consisted of only 45 patients (14). In the fifth study (19), symptoms severity in 94 patients were assessed at 1 and 4 months after surgery. The lack of a preoperative symptom assessment makes it difficult to distinguish the symptoms that the patients experienced before and after surgery. The lack of preoperative symptom assessment is a significant limitation because lung cancer patients seem to have a high number of comorbidities than other patients (21). These two studier only focused on either symptom distress (14) or symptom severity (19). Therefore, we wanted determine if, multiple dimensions of the patients’ symptoms experience change from before to following lung cancer surgery. 2.5 Symptoms influence on rehabilitation This study follows the patients’ from before to five months after surgery. At five months after surgery is the period of time when patients start the rehabilitation process. Cancer rehabilitation is defined as helping a person with cancer to help himself or herself obtain maximum physical, social, psychological, and vocational functioning (e.g., optimal working performance) within the limits imposed by the disease and its treatment (69). The aim of rehabilitation is to improve the quality of survival so that patients will be as comfortable and productive as possible and can function at a minimum level of dependency regardless of life expectancy (70). 24

Findings from two studies suggest that, compared to the general population, lung cancer patients have a poorer QOL prior to surgery (71, 72). In addition, one month after surgery, their QOL decreases compared to preoperative ratings (14, 17, 18, 73). However, findings regarding changes in QOL scores in months following surgery are inconsistent. While some studies found that patients’ QOL returned to pre-surgical levels at 3 to 6 months after surgery (16, 18, 73, 74), others reported that QOL remained impaired for up to 2 years after surgery (17, 75). A reduction in QOL can have a major impact on patients’ lives because it is associated with difficulties in fulfilling family roles; reductions in their inability to work; and reductions in their ability to participate in common social activities (76). If patients experience multiple symptoms in the rehabilitation period, it could affect the progress of their rehabilitation, because multiple symptoms are associated with significant decreases in functional status and QOL (77). In addition, while symptoms are a major problem for patients, they can be a problem for their family caregivers. Due to a lack of follow-up care for these patients, symptom management often becomes a family member’s responsibility (78). Cancer and its treatments may cause physical impairments and psychological distress in survivors (79). While limited research is available on lung cancer patients lives after surgery, the findings suggest that lung cancer patients have a poorer performance status after surgery compared to other cancer patients (80). Rehabilitation and physical activity can help patients recover from surgery. The European Respiratory Society (ERS) and the European Society of Thoracic Surgery (ESTS) clinical guidelines on fitness for radical therapy in lung cancer patients (45) recommend early pre- and postoperative rehabilitation in patients with 25

operable lung cancer. Factors that are important in rehabilitation of surgically treated lung cancer patients include; increased physical activity, smoking cessation, and avoidance of malnutrition (81). In a recent study (82), the introduction of a standardized aerobic endurance training program as part of the inpatient rehabilitation of patients with lung cancer resulted in significant improvements in both physiological and psychological parameters after lung cancer surgery. 2.6 Comorbidities effect on symptoms Comorbidity is the presence of one or more additional medical conditions that can co-occur with a primary disease or disorder (83). The prevalence of comorbidities among lung cancer patients is about twice as high as in the general population (21). Findings regarding whether the presence of comorbidities affect survival in patients with NSCLC are inconclusive (84, 85). In one study (84), the presence of comorbidities reduced survival. In another study (85), no association was found. The most common comorbidities in patients with lung cancer are cardiovascular disease, emphysema/chronic obstructive pulmonary disease (COPD), and hypertension (19, 85). The presence of comorbidities is associated with a variety of symptoms and can influence the severity of symptoms in lung cancer patients (16, 19). However, studies on the relationships between comorbid conditions and the QOL of patients following lung cancer report divergent results (86-88). Two of these studies found that a higher number of comorbid conditions was associated with poorer physical and mental QOL (87, 88). In contrast, another study found no association between number of comorbid conditions and QOL (86). Additional research is needed to

26

confirm or refute these findings, and to examine further the impact that comorbid conditions have on symptoms. 2.7 Summary and critique of previous research on symptoms in patients undergoing surgery for lung cancer Few studies have evaluated patients’ symptom burden before and after lung cancer surgery (14, 16-19). Symptoms like; cough, pain, dyspnea, loss of appetite, fatigue, and insomnia were most common before surgery. The occurrence rates of several of these symptoms increased significantly after surgery (14, 16-19). Findings regarding further change in symptoms after surgery are inconsistent. The studies reported either that the symptom rates were back to preoperative levels 4-6 months after surgery (18), or that patients still experienced a high symptom burden (14, 16, 17, 19). These previous studies provided interesting information (14, 16-19), but had several limitations (i.e., reported data on a limited number of symptoms and only occurrence, distress or severity rates for these symptoms). However, it seems like lung cancer patients have a poorer performance status after surgery compared to other cancer patients (80). 2.8 Theory of Symptom Management (TSM) The Theory of Symptom Management (TSM) was chosen as the theoretical framework for this study (10). The TSM is a middle range theory that can be used to guide symptom assessment and treatment in nursing practice. In addition, the TSM can be used to guide the development of hypotheses for nursing research (10). A middle range theory is a theory with limited scope, that explains a specific set of phenomena, in a discipline (89).

27

The TSM was first introduced as the Symptom Management Model by faculty members at the University of California, San Francisco (UCSF) in 1994 (78). The theory was further tested and discussed by students and faculty members at UCSF. Revised models were published in a journal in 2001 (62), and later as a chapter entitled “Theory of Symptom Management” in the third edition of the book “Middle Range Theory for Nursing”(10).

Figure 1. Model of the three essential dimensions of the TSM, the symptom experience, symptom management strategies, and symptom status outcomes. (Figure reproduced with permission from John Wiley and Sons. Copyright © 2008. All rights reserved.)

As illustrated in Figure 1, the three essential dimensions of the TSM are symptom experience, symptom management strategies, and symptom status outcomes (10). The symptoms experience dimension is defined as a perception, evaluation, and a response to a change in the person’s usual feelings (10). Patients 28

evaluate their symptoms by making judgement about the severity, cause, treatability, and effect of symptoms on their lives (62). The symptom management strategies dimension is defined as efforts to avert, delay, or minimize the symptom experience. Interventions to manage symptoms can be initiated by the health care provider or by patient or family members. The reduction in symptoms can be done by either reducing the frequency, the severity, or the distress associated with a symptom (90). The final dimension (i.e., symptom outcome) is defined as a change in a symptom’s status. The change in symptom status can be that the symptom is less frequent, less intense, or less distressing. Factors like functional status, QOL, comorbidity, and morbidity will influence patients’ symptom outcomes. The three essential dimensions are nested within the three domains of nursing science (i.e., person, environment, health/illness). Personal factors, environmental factors, and a person’s health/illness will influence a person’s symptom experience. For instance, a woman’s symptom experience is described to vary by age (person domain), her cultural beliefs about the symptom (environmental domain), and her current state of health (health/illness domain) (10). A simultaneous interaction exists among the symptom experience, symptom management strategies, and symptom status outcomes. The TSM has been used in different ways in several studies (10, 91, 92). However, to our knowledge this study is the first to use the TSM in a sample of patients with lung cancer who were evaluated before and following surgery. The TSM illustrates the complexity of the patients’ symptom experience. The TSM was used when the study was planned; it guided both the longitudinal design of the study, the selection of questionnaires, and which demographic and clinical characteristics were 29

collected. Further, the TSM guided the data analysis and the interpretation of the results. The TSM provided guidance on the important variables to evaluate both in this research study and in the clinic. Given the limited amount of evaluation on multiple dimensions of the symptom experience of lung cancer patients and how the symptoms change from before to following surgery, this study focused on the symptom experience dimension. Based on the findings from this study, subsequent intervention studies can be planned to decrease symptoms and improve rehabilitation outcomes in these patients.

30

AIMS OF THE STUDY The main aims of this clinical, interdisciplinary, multi-center, and international research study with 264 lung cancer patients were to evaluate patients’ symptom experiences before and after lung cancer surgery and to explore how demographic and clinical factors influenced these symptom experiences. The specific aims were: The aim of paper 1 was to evaluate for differences in the symptom experience (i.e., RFFXUUHQFHVHYHULW\GLVWUHVV EHWZHHQROGHU•\HDUV DQG\RXQJHU\HDUV  patients using a multidimensional symptom assessment scale (i.e., Memorial Symptom Assessment Scale (MSAS)). The aim of paper 2 was to evaluate for changes in symptom occurrence and severity from the preoperative period to 1 month after surgery. In addition, the associations between select demographic (i.e., age, gender, living situation) and clinical characteristics (i.e., preoperative FEV1, comorbidity, stage of cancer, extent of surgery, postoperative complications), as well as the number of preoperative symptoms, and the number of symptoms reported at 1 month after surgery were evaluated. The aim of paper 3 was to evaluate for changes in symptom occurrence and severity from the preoperative period to 5 months after surgery and to evaluate for predictors of symptom occurrence and severity for seven of the most common symptoms.

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4.0 METHODS A longitudinal study that included 270 patients with presumptive primary lung cancer over 12 months was initiated in 2010. A longitudinal design is appropriate to study a phenomenon’s development over time (93). Patients were recruited from three University Hospitals in different health regions in Norway. Data on demographic and clinical characteristics, comorbidities, symptoms, and QOL outcome were collected and used in this thesis. Patients filled in the Memorial Symptom Assessment Scale (MSAS), the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire with its lung specific module (LC13), and the Selfadministered Comorbidity Questionnaire (SCQ) preoperatively, and again at 1 and 5 months after surgery. Only data from the 3 item dyspnea scale of the EORTC QOLLC13 (i.e., SOB at rest, SOB walking, SOB climbing stairs) were used in this thesis. Patients were assessed prior to surgery, and at 1, 5, 9, and 12 months after surgery. Due to the time constraints of doctoral study, only data from the preoperative, one month, and 5 month assessment were analyzed for this thesis. Results from the 9 and 12 month assessments will be published after the thesis is completed. Most patients completed the preoperative assessment in the hospital. For the remaining assessments, patients received the questionnaires at home and returned them to the research office by mail. The one and five month time frames were chosen to evaluate the patients’ symptom experience following surgery, as well as prior to and after the administration of adjuvant CTX. 4.1 Patients and settings Patients were recruited from three university hospitals in Norway (i.e., Oslo University Hospital, St. Olav University Hospital in Trondheim, Haukeland University 32

Hospital in Bergen). The recruitment of patients started in October 2010 at Oslo University Hospital (OUS). Patients were recruited on the surgical ward prior to surgery (i.e., the pulmonary division at Rikshospitalet, patient hotel at Ullevål). At each institution, two nurses were trained to assist with patient recruitment when the PhD student was not present. A check list and a description of the information that needed to be provided to the patients were developed and used by these recruitment nurses (Appendix 1 and 2). In November 2010, recruitment started at St. Olav University Hospital and in March 2011 at Haukeland University Hospital. The recruitment of patients at these clinics was done by nurses in the pulmonary outpatient clinics and in the division of thoracic surgery. The PhD student insured that identical procedures were followed at all of the recruitment sites. The recruitment of patients was completed in March 2012. 4.1.1 Inclusion criteria Patients were included if they weUHDGXOWV•\HDUVRIDJHZHUHDEOHWRUHDG write, and understand Norwegian; and were scheduled for surgery for primary lung cancer. Patients were excluded if they were cognitively impaired; their surgery was cancelled; or if the histological examination after surgery revealed that they had benign or metastatic disease. The research staff discussed with the responsible nurse and physician if the patient was cognitively impaired and if they were able to read, write, and understand Norwegian. If the clinicians were uncertain, patients were asked if they thought they were able to complete the questionnaires. 4.2 Study procedures Research staff approached the patient and explained the purpose of the study. After obtaining written informed consent (Appendix 3), patients completed the 33

enrollment questionnaires (Appendix 4). The majority of the patients (91%) were recruited in the hospital one to three days before surgery. The remaining 9% of the sample was recruited in the outpatient clinic prior to surgery. At one and five months after surgery, patients were sent the study questionnaires and asked to return them using a postage paid envelope. The patients who did not return the questionnaires were sent one reminder after about 2 weeks. When they enrolled in the study, patients were offered support to complete the questionnaires from the PhD student or the research nurse; if they expressed problems. The patients were given a mobile phone number and an e-mail address they could use to contact the staff if they had any questions about or reactions to the questionnaires that were mailed to them at 1 and 5 months after surgery (Appendix 5). The information about the possibility to withdraw from the study was repeated at all measurements points. 4.3 Study Variables and Instruments Study measures were obtained through a set of multi-item questionnaires. In addition, data were abstracted from patients’ charts. Measures and data collection time points are listed in Table 2. When the questionnaires were completed and returned, the forms were scanned by a company, and the results were transformed to a SPSS data file. Then, the PhD student checked the questionnaires against the scanned data file for any errors.

34

Table 2. Measures and data collection time points Concepts measured

Instruments

Patient demographics

Study specific

Clinical and medical information

Data source

Study months 0

1

5

Qnaire / charts

X

X

X

Study specific

Qnaire / charts

X

X

X

Comorbidity

SCQ

Charts

X

Symptoms (general)

MSAS

Qnaire

X

X

X

Quality of life

EORTC QLQC30+LC13

Qnaire

X

X

X

X

4.3.1 Demographic and clinical characteristics Information about demographic and clinical characteristics were collected either from the patients or from their medical records. Patients provided information on gender, marital status, living situation, level of education, and employment status. Patients’ medical records were reviewed for information on age, lung function, height, weight, and use of preoperative medications, tumor histology, type of surgery, and TNM classification (94). A case report form (CRF) was developed to ensure that this information was collected from the medical records of all patients (Appendix 1). The PhD student or the research nurse completed the CRF based on information found in the patient’s medical record. The PhD student picked up the CRFs at the different hospitals and brought the forms to OUS. The PhD student evaluated all of the CRF forms for completions and obtained any missing data prior to entering the information into the SPSS database. Information on smoking status was collected at all three assessments. The initial information on smoking status (i.e., pre-operative assessment) was obtained 35

from the patients’ medical records. At the 1 and 5 month assessments, the patients provided information about smoking. Preoperative information about smoking status included: when they started and eventually stopped smoking and the number of cigarettes smoked daily. This information is important for the calculation of number of pack-years, which is the unit to measure the amount a person has smoked over time. One pack-year is 20 cigarettes smoked/day for one year (95). Based on information about smoking history, the patients were divided into three groups; never smoked, previous smokers, and current smokers. At one and 5 months after surgery, the patients were asked if they were smoking (i.e., yes/no) and if they had stopped smoking in the period since the last assessment. Patients’ lung function was measured by spirometry preoperatively and their FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) values were recorded in their medical records. FVC is the volume of air that can forcibly be blown out after full inspiration. FEV1 is the volume of air that can forcibly be blown out in the first second after full inspiration. Predicted normal values for FEV1 and FVC are calculated based on an individual’s age, sex, height, weight, and ethnicity. By comparing the measured FEV1 and FVC with the predicted normal values, the percent of expected FEV1 and FVC were calculated (96). Patients’ height and weight were recorded from the medical records. Body mass index (BMI) was calculated. BMI is a formula that determines whether an individual has the correct weight for their height (97). 4.3.2 Comorbidity questionnaire To measure comorbidity, the Self-administered Comorbidity Questionnaire (SCQ) was chosen because it was used in another study of Norwegian cancer 36

patients and found to be a useful and reliable scale (98, 99). The SCQ was completed at the preoperative and 5 month assessments (Appendix 4). The SCQ includes 16 common comorbidities and three optional conditions (100). Patients indicated whether or not they had the comorbid condition (yes/no); if they had the condition they were asked if they received treatment for it (yes/no); and finally if it limited their activities (yes/no). The SCQ can be scored in two different ways (i.e., a sum score, a total score). The sum score is a count of the number of comorbid conditions and can range from 0 to 19. The total SCQ-19 score ranges from 0-57. An individual can receive a maximum of 3 points for each medical condition: 1 point for the presence of the condition, another point if he/she receives treatment for it, and an additional point if the condition causes a limitation in function. Because the SCQ contains 16 defined medical conditions and 3 optional conditions, the maximum score totals 57 points if the open ended items are used and 48 points if only the close-ended items are used (100, 101). A higher total score indicates a more severe comorbidity profile. The SCQ was used to assess comorbidity in Norwegian oncology patients in previous studies (98, 99). The SCQ was translated into Norwegian using a standard forward backward translation procedure. The SCQ was tested on medical and surgical patients; test-retest reliability of the SCQ was shown to be 0.94 calculated by the intraclass correlation coefficient and 0.81 by the Spearman correlation coefficient (100). 4.3.3 Symptoms assessment scale Several instruments are available to measure multiple symptoms in cancer patients. In one review (67), three questionnaires were considered to be valid and 37

reliable instruments to measure multiple symptoms in cancer patients at different stages of their disease. The three instruments were: Symptom Distress Scale (102), M. D. Anderson Symptom Inventory (103), and Memorial Symptom Assessment Scale (MSAS) (90). The Symptom Distress Scale is a 13-item self-report instrument that assesses the level of distress associated with 13 symptoms. The M. D. Anderson Symptom Inventory measures the severity of 10 physical symptoms, three psychological symptoms, and six interference items (103). The MSAS assesses the occurrence, frequency, severity, and distress of 32 symptoms (90). The MSAS was selected because it assesses a broad range of symptoms across multiple dimensions of the symptom experience. The Memorial Symptom Assessment Scale (MSAS) is a patient-rated instrument that was developed to provide multidimensional information about common symptoms (Appendix 4). The scale contains a list of 32 physical and psychological symptoms. Patients completed the questionnaire prior to surgery and at 1 and 5 months. Patients were asked to indicate whether or not they had the symptom during the past week (i.e., symptom occurrence). If they experienced the symptom, they were asked to rate its frequency, severity, and distress. Symptom frequency was rated using a four-point Likert scale (1= rarely, 2 = occasionally, 3 = frequently, 4 = almost constantly). Symptom severity was rated using a four-point Likert scale (1= slight, 2 = moderate, 3 = severe, 4 = very severe). Symptom distress was rated using a five-point Likert scale (i.e., 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). The MSAS is a reliable and valid instrument for the assessment of symptom occurrence, severity, and distress (90). During its development the validity of MSAS 38

was tested using a number of approaches. To test the concurrent validity of the MSAS, relationships between symptoms scores and functional status (measured using the Karnofsky Performance Status (KPS) scale) and QOL (measured using the FLIC) scores were evaluated. Patients with an increased symptom burden had lower functional status and QOL scores (90). The construct validity of MSAS was evaluated by comparing MSAS scores in different subpopulations. As expected, inpatients had higher distress scores than outpatients. In addition, patients with more advanced disease were more symptomatic than patients with earlier stage disease (90). Previous research used the MSAS to evaluate symptoms in Norwegian oncology patients (63). It was translated into Norwegian using a standard forwardbackward translation procedure. Before it was used in a longitudinal study with 188 breast cancer patients (63), it was pilot tested with 10 breast cancer patients. Only minor linguistic adjustments were needed after the pilot testing. 4.3.4 Quality of life questionnaire with a lung cancer specific module Numerous instruments are available to assess QOL in oncology patients. The most frequently used questionnaires to measure the QOL of lung cancer patients before and after surgery are the Medical Outcomes Study - Short Form Health Survey 36 (SF 36) (55) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (55, 104). In this study, the EORTC QOL questionnaire (Appendix 4) (105) was selected because this questionnaire was developed to measure QOL in cancer patients, and to be able to compare the results from our study with previous research. In addition, it has a lung cancer specific module (i.e., LC13) that measures lung cancer associated symptoms and side effects

39

from treatment (106). However, in this study, only the lung cancer specific module (i.e., LC13) was used because it has specific items for lung cancer patients. The EORTC QOL core questionnaire consists of 30 items (105). It includes five functional scales (i.e., physical, role, emotional, social, cognitive), three symptom scales (i.e., fatigue, pain, nausea/vomiting), a global health status/QOL scale, and a number of single items that assess additional symptoms and perceived financial impact. This cancer specific, multidimensional questionnaire was tested in different cultures and was translated into several languages, including Norwegian (107). The EORTC QOL-LC13 is a disease specific module, that assesses lung cancer specific symptoms including cough, hemoptysis, dyspnea, and pain as well as side effects associated with CTX and RT therapy (106). Patients were asked to rate the severity of the symptom using a four-point Likert scale (i.e., 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). Responses to the QLQ-LC13 questionnaire were scored according to procedures specified in the EORTC scoring manual (108). EORTC QLQ-LC13 was validated in Norwegian patients. It was found to be a clinically valid and a useful tool to assess disease- and treatment-specific symptoms in lung cancer patients when it was combined with the EORTC QOL core questionnaire (106). In this thesis, only the three item dyspnea scale from the EORTC QOL-LC13 was used (i.e., SOB at rest, SOB walking, SOB climbing stairs). 4.4 Statistics All analyses were done using SPSS version 20 and STATA Version 13. For all tests, a p-YDOXHRI‫ޒ‬ZDVFRQVLGHUHGVWDWLVWLFDOO\VLJQLILFDQW'HVFULSWLYHVWDWLVWLFV were used to present demographic and clinical characteristics of the sample. Means

40

and standard deviations were generated for quantitative variables and frequencies and percentages for categorical variables. Paper 1 In the first paper, a cross sectional design was used. Cross-sectional studies are appropriate for describing the status of a phenomenon, or the relationship between phenomena, at a fixed point in time (93). This paper evaluated for GLIIHUHQFHVLQV\PSWRPRFFXUUHQFHVHYHULW\DQGGLVWUHVVEHWZHHQROGHU•\HDUV  and younger (30% of lung cancer patients reported this symptom several years after surgery and it had a significant negative impact on their QOL. One factor that may influence the occurrence and severity of SOB is smoking. Of note, 94% of the patients in this study were current or previous smokers. Another 72

factor that could influence SOB is pain (132, 133). In a study of COPD patients with dyspnea and pain (133), their two symptoms appeared to create a vicious cycle. Five months after surgery, 56% of the patients in the present study reported pain and 36% were still using analgesics’ (Paper 3). The International Association for the Study of Pain (IASP) defines chronic pain after thoracotomy as pain that persists for at least 3 months after the surgical procedure (134). The finding that more than 50% of the patients reported pain after surgery in the present study is consistent with findings from previous studies (126, 135). Three of the 7 symptoms reported 5 months after surgery are known to be interrelated: namely lack of energy, difficulty sleeping, and feeling drowsy (64). Few studies have explored the consequences of feeling drowsy in cancer patients. However, both lack of energy and difficulty sleeping are often documented to significantly impair patients’ QOL and ability to function (127, 136). Previous studies in lung cancer patients have measured only lack of energy and difficulty sleeping. One study reported that lack of energy returned to pre-surgical levels 6 months after surgery (18). In the other two studies (17, 19), fatigue scores remained elevated for up to two years. Difficulty sleeping was reported in only one study (18), and was found to be a frequent problem preoperatively. The severity of cough decreased over the first month then it increased from 1 month to 5 months (Paper 3). A previous study found the same pattern for cough. The authors hypothesized that patients suppressed cough shortly after surgery due to pain (18). Regardless of the cause, cough is a distressing symptom and has important implications for the QOL of lung cancer patients (137, 138).

73

Worrying was the most frequent psychological symptom in the present study. Forty-seven percent of the patients reported this symptom at 5 months (Paper 3). A previous study reported that 51% of patients experienced worrying to be at least “somewhat of a problem” and that high levels of preoperative worry were associated with a significantly higher number of symptoms even before treatment (139). Patients in this study reported other psychological symptoms like feeling nervous (40%) and feeling sad (37%). The high rates of psychological symptoms as measured here may be related to patients’ cancer diagnosis (140). Previous studies found that psychological symptoms in lung cancer patients continued for up to a year and that these patients need psychological support (141, 142). Of note, 43% of the patients reported problems with sexual interest preoperatively and at 5 months 47% of the patients reported this symptom. Problems with sexual interest was the most frequent, severe, and distressing symptom at 5 months. This symptom was not assessed in the previous studies of symptoms in surgically treated lung cancer patients (14, 16-19). However, in a previous study in lung cancer patients receiving different kind of cancer treatment (15), this symptom was described as severe. In a large study of causes and consequences of sexual changes after cancer, this symptom was described as distressing and causing relationship difficulties (143). Qualitative interviews with health professionals and patients revealed that they had different foci with regard to sexual problems (144). While patients wanted information, support, and practical strategies about how to live with intimate and sexual changes after treatment for cancer, health professionals focused on patients’ fertility, contraception, menopausal status, or erectile status (144). This finding warrants additional research to determine how clinicians assess sexual problems in patients with cancer (144). 74

6.2.1.4 Summary of the symptoms The patients in this study experienced a high symptom burden over time. Both before and after surgery, symptoms like lack of energy and SOB had high occurrence rates, as well as high severity, frequency, and distress scores. However, pain was a symptom that increased the first month after surgery and remained quite high at five months. In contrast, the occurrence of cough was high at all three assessments. However, cough was not among the most frequent, severe, or distressing symptoms at five months. Psychological symptoms like worrying, feeling sad, or feeling nervous were common preoperatively, and their occurrence rates remained relatively high at one and five months after surgery. These differences suggest the need for detailed symptom assessments of patients before and after surgery in order to be able to implement effective symptom management interventions. 6.2.2 Demographic and clinical characteristics that influence symptom burden Demographic and clinical characteristics had differential effects on patients’ symptom experiences. The analyses in Paper 2 and 3 gave different results in terms of which characteristics influenced patients’ symptom experience. These differences may be because various characteristics differ in their contributions over time. In paper 2, which assessed changes in symptoms from the preoperative period to one month after surgery, we found that the only characteristic that was associated with a higher number of postoperative symptoms was the number of preoperative symptoms reported by the patient. This finding was a bit unexpected because previous studies of lung cancer patients reported that demographic characteristics (i.e., age, gender, living situation) and clinical characteristics (i.e., preoperative FEV1, comorbidity, stage of cancer, extent of surgery, postoperative complications) were 75

associated with QOL and symptom scores reported 1 month after surgery (55, 86, 125). However, the multilevel growth model that assessed the trajectories of symptoms showed that age, comorbidities, receipt of adjuvant CTX, and gender influenced the change in the occurrence and severity of symptoms to a different extent. The possible reasons for these differences are discussed under each demographic and clinical characteristic. 6.2.2.1 Age As previously mentioned, one of the initial purposes of this study was to evaluate symptom burden in surgically treated elderly lung cancer patients. We hypothesized that elderly patients would experience more symptoms than younger patients. In the initial analyses few age-related differences were found between older and younger patients. When age differences were identified, older patients reported lower symptom occurrence rates and lower severity and distress ratings (Paper 1 and 3). Preoperatively, when 32 symptoms were assessed, older patients reported lower occurrence rate for feeling drowsy; a lower severity score for feeling nervous; and a lower distress rating for lack of energy (Paper 1). In the second paper, when we evaluated for changes in symptom occurrence rates and severity ratings, from the preoperative period to 1 month after surgery, no age-related differences were found. In the third paper, when we analyzed the trajectories of symptom occurrence rates and severity ratings from before through five months after lung cancer surgery; age influenced the occurrence rates for pain and feeling drowsy, and demonstrated a

76

cross level interaction (i.e., influenced the change in symptoms over time) with the severity of SOB when climbing stairs. A limited number of studies have evaluated the associations between age and the occurrence, severity, and distress of symptoms (117). To our knowledge, the one study that focused on age differences in symptoms of lung cancer patients evaluated symptom distress in newly diagnosed lung cancer patients (145). The study reported that older patients experience less symptom distress than younger patients. One reason why older patients report fewer symptoms may be that they are referred to the thoracic surgeon earlier than younger patients (140). Another explanation may be that older persons experience a “response shift” in symptom perceptions. A “response shift” is a change in a person’s internal standard, in values, or in the conceptualization of experiences that are catalyzed by a change in their health status (146). Older patients may have experienced symptoms from other medical conditions for a long time which may have resulted in a reconceptualization of their symptoms (147). The results from other studies on age related differences in symptoms are inconsistent (117, 145, 148-150). In a study of oncology patients undergoing radiation therapy (RT) (149), sleep disturbance, pain, and distress were significantly less prevalent among older patients compared to younger patients, while SOB was significantly more prevalent among older patients. In another study of multiple symptoms in patients newly diagnosed with gastrointestinal cancer (150), patients >70 years of age reported higher symptom distress scores compared to patients 70 years of age (44). Recent studies found that patients who were •\HDUVRIDJHEHQHILWHGIURPDGMXYDQW&7;DIWHUVXUJHU\(155, 156), and even patients at 75 years had the same clinical and pathological characteristics as younger patients (157). However, in those over 80 years of age, no additional survival benefit was realized (156). The presence of comorbid disease was prognostic in this retrospective study and may be a more relevant inclusion or exclusion criteria for treatment than chronologic age (84). 6.2.3 Consequences and treatment of a high symptom burden The patients in this study had a high symptom burden at 5 months after surgery. This finding is important because the occurrence of multiple symptoms is 80

associated with decreased functional status and QOL (67) and will have a negative effect on patients’ rehabilitation process (69). Lung cancer patients appear to have a larger number of unmet psychosocial and daily living needs than other cancer patients (30, 158). Many patients report that life after a lung cancer diagnosis is difficult and that their concerns are not being met (19, 140, 159). In addition, lung cancer patients experience added difficulties and stigma because of the close connection between the disease and smoking (160-162). Patients experience stigma to a different degree. Of note, higher levels of lung cancer stigma (LCS) were associated with higher levels of anxiety and depression, as well as poorer QOL (160, 161). It is important to give these patients and their family members information at hospital discharge about how to manage their symptoms and when to seek care for unrelieved symptoms (9). Close follow-up and assistance with symptom management are extremely important. The Norwegian guideline for diagnosis, treatment, and follow-up of lung cancer patients recommends that patients should be seen at 1 month after surgery, then every 3 months until 9 months after surgery (44). However, based on the high symptom burden of lung cancer patients after surgery, these patients may need closer follow-up and more assistance with symptom management either in the hospital or in an outpatient clinic. Cancer patients are vulnerable to an overall decrease in activity. An early intervention can prevent problems, as it is much easier to maintain strength and range of motion than to regain it (69). Rehabilitation can play a role in improving tolerance to treatment and adaption to disability (23). The European Respiratory Society (ERS) and the European Society of Thoracic Surgery (ESTS) clinical 81

guidelines on fitness for radical therapy in lung cancer patients (45) recommend early pre- and postoperative rehabilitation in operable lung cancer patients. In the present study, 42% of the patients received physical therapy and/or inpatient rehabilitation. When total number of symptom was compared between that patients’ who did and did not receive physiotherapy/rehabilitation, no differences were found. However, we lack knowledge about when the patients received physiotherapy, as well as how much and what type of physiotherapy they received. Both the Medical Research Council and the developers of the TSM noted that the intervention itself, as well as the timing and dose of the intervention are important considerations when evaluating an interventions effect (10, 24). A systematic review of exercise interventions for patients surgically treated for NSCLC concluded that even though the quality of the evidence has many limitations, it appears that an exercise intervention improved patients’ cardiopulmonary exercise capacity, increases their muscle strength, and reduces fatigue, post-operative complications and hospital length of stay (122). In a recent Norwegian study (123) , high-intensity training following lung cancer surgery improved peak oxygen uptake, muscular strength, total muscle mass, functional fitness, and QOL. Until further studies are done, referrals to physical therapy or rehabilitation programs need to be considered for all patients who undergo lung cancer surgery. 6.3 Theory of Symptom Management (TSM) The initial purpose of this study was to develop an intervention to improve symptom management in surgically treated lung cancers patients. This plan was under consideration, because in a previous, small, qualitative study done by our 82

research group, patients described a postoperative period characterized by discomfort and lack of support from clinicians (12). However, when a literature review was done; lack of knowledge about surgically treated lung cancer patients’ symptom experience was identified. This paucity of research made the development of a tailored and effective symptom management intervention difficult. The Medical Research Council (MRC) in United Kingdom clearly states that an intervention should be systematically developed based on previous evidence (24). It is also emphasized that if factors that caused and sustained the problem were not well understood, one needed to do some primary research to understand the phenomes of interest (24, 25). Starting with the collection of data on patients’ symptom experience is consistent with how knowledge development was done in previous studies of symptoms in other patient groups (e.g., COPD, diabetes) (10). First studies on patients’ symptom experiences were done. Then symptom management interventions were developed and evaluated, first in terms of efficacy and then in terms of clinical effectiveness. The TSM was used as the theoretical framework for this study, because this theory describes how to assess symptoms and how to develop interventions to relieve patients’ symptom burden. The theory was useful in clarifying the characteristics that may influence the patients’ symptom experience (i.e. personal, environmental, health &illness), and how both the frequency and severity of a symptom influences the level of distress associated with a symptom. In addition, the theory explains how different types of interventions (symptom management

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strategies) can change patients’ symptom experiences as well as associated outcomes (symptom outcomes). The main focus in this study was on the symptom experience dimension of the TSM. However, in addition to the data collection on patients’ symptom experience, we explored the relationships between symptom experience and some demographic and clinical characteristics in the three domains of nursing science (i.e., person, environment, health & illness). Data were collected on how age and gender from the person domain affects patients’ symptom experience. In addition, we evaluated how comorbidity, receipt of adjuvant CTX, and number of preoperative symptoms from the health & illness domain affected patients’ symptom experience. We also collected some information on symptom management strategies (i.e. rehabilitation, physiotherapy) and symptom status outcome (i.e. patients employment status, SOB at rest, SOB when walking, SOB climbing stair) symptom. In this study, we collected data about which symptoms had the highest occurrence rates as well as which symptom were the most severe, distressing, and frequent at different assessment points. This information is a good starting point to develop and test an intervention to relive symptoms in surgically treated lung cancer patients. The next step in our research group will be to develop and test symptom management interventions to ease patients’ symptom status; either by making the symptom less frequent, less intense, or less distressing. The best way to develop and test interventions is by starting with a series of pilot studies, and moving on to exploratory studies and then to a definitive evaluation (24). This approach is called a pragmatic design (163). When these pilot testes are done, it is possible to design and conduct a randomized controlled trial; where on group of patients receives the 84

intervention and the other group receives either standard care or some type of alternative control intervention. Then the effects of the intervention on patients’ symptoms could be evaluated.

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7.0 CONCLUSIONS AND CLINICAL IMPLICATIONS This dissertation provides evidence that surgically treated lung cancer patients experience a high symptom burden. At 5 months, the number of symptoms was significantly higher than at the preoperative assessment. This high symptom burden in lung cancer patients before and after surgery requires that clinicians perform a comprehensive symptom assessment prior to surgery and at regular intervals after surgery. Psychological symptoms (e.g., worrying) were common, especially preoperatively, and warrant consideration because of their negative effects on postoperative outcomes (164). It is important that clinicians speak with patients about their concerns and initiate referrals to mental health professionals if warranted. The findings from this study can be used to identify patients who are at higher risk for more severe symptoms before and after lung cancer surgery and to initiate more aggressive symptom management interventions. Patients with comorbidities and a higher number of preoperative symptoms need special attention because they tend to experience a higher number of postoperative symptoms. The results in this study can be used to improve the information given to the patients about the normal course of postoperative recovery after lung surgery. More knowledge about which symptoms are expected after lung cancer surgery and how to cope with these symptoms can make the rehabilitation period easier for the patients. Even though it is recommended (45), less than 50% of the patients in this study received physical therapy or inpatient rehabilitation. The number of patients who worked decreased from 30% preoperatively to 9% at five months after surgery. In summary, this clinical, interdisciplinary multi-center, study with 264 lung cancer patients provides important information on the symptom burden of these 86

patients who underwent lung cancer surgery. This information can be used to develop tailored symptom management interventions and that may significantly improve postoperative and survivorship outcome for this group for this group of patients.

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8.0 FUTURE RESEARCH Additional studies are needed to confirm the findings from this study. For example, future studies could evaluate if patient who undergo different types of surgical procedures (e.g., thoracotomy or VATS) have different symptom experiences. It would be interesting to see if other studies find similar patterns as in this study, namely that younger lung cancer patients experience a higher symptom burden than older patients. Future studies could evaluate for subgroups of patients which experience higher symptom burden, using statistical approaches like latent class analyses (165, 166). In addition, future studies could evaluate for the number and types of symptom cluster in these patients and whether the number and types of symptom cluster change over time. Additional research needs to focus on the etiology of the symptoms identified. In addition, it is important to develop and test symptom management interventions to improve symptom management in these patients. It is important that these interventions focus on multiple symptoms and that they help patients to cope with their symptom burden. Future studies could focus on additional elements of the TSM. For example, studies could focus on the impact of symptom management strategies on the patients’ symptom experience. Then it would be possible to evaluate how this intervention influences symptom outcomes. This change in symptom status can either be that the symptom is less frequent, less intense, or less distressing, or remains the same. The assessment should be longitudinal as symptom burden varies over time. In addition, one could evaluate whether changes in symptom status has an impact on a variety of symptom outcomes (e.g., QOL, return to work)

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137. Harle AS, Blackhall FH, Smith JA, Molassiotis A. Understanding cough and its management in lung cancer. 2012;6(2):153-62. 138. Molassiotis A, Lowe M, Ellis J, Wagland R, Bailey C, Lloyd-Williams M, et al. The experience of cough in patients diagnosed with lung cancer. Support Care Cancer. 2011;19(12):1997-2004. 139. Stefanek ME, Shaw A, DeGeorge D, Tsottles N. Illness-related worry among cancer patients: prevalence, severity, and content. Cancer Invest. 1989;7(4):365-71. 140. Hill KM, Amir Z, Muers MF, Connolly CK, Round CE. Do newly diagnosed lung cancer patients feel their concerns are being met? Eur J Cancer Care (Engl). 2003;12(1):35-45. 141. Oh S, Miyamoto H, Yamazaki A, et al. Prospective analysis of depression and psychological distress before and after surgical resection of lung cancer. General Thoracic and Cardiovascular.2007; 55 (3):119-24. 142. Uchitomi Y, Mikami I, Nagai K, Nishiwaki Y, Akechi T, Okamura H. Depression and psychological distress in patients during the year after curative resection of non-small-cell lung cancer. J Clin Oncol. 2003;21(1):69-77. 143. Ussher JM, Perz J, Gilbert E. Perceived causes and consequences of sexual changes after cancer for women and men: a mixed method study. BMC Cancer. 2015;15(1):268. 144. Hordern AJ, Street AF. Communicating about patient sexuality and intimacy after cancer: mismatched expectations and unmet needs. Med J Aust. 2007;186(5):224-7. 145. Degner LF, Sloan JA. Symptom Distress in Newly-Diagnosed Ambulatory CancerPatients and as a Predictor of Survival in Lung-Cancer. J Pain Symptom Manage. 1995;10(6):423-31. 146. Schwartz CE, Sprangers MA. Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Soc Sci Med. 1999;48(11):1531-48. 147. Costanzo ES, Ryff CD, Singer BH. Psychosocial adjustment among cancer survivors: findings from a national survey of health and well-being. Health Psychol. 2009;28(2):147-56. 148. Cheung WY, Le LW, Gagliese L, Zimmermann C. Age and gender differences in symptom intensity and symptom clusters among patients with metastatic cancer. Support Care Cancer. 2011;19(3):417-23. 149. Mohile SG, Heckler C, Fan L, Mustian K, Jean-Pierre P, Usuki K, et al. Age-related Differences in Symptoms and Their Interference with Quality of Life in 903 Cancer Patients Undergoing Radiation Therapy. J Geriatr Oncol. 2011;2(4):225-32. 150. Yan H, Sellick K. Symptoms, psychological distress, social support, and quality of life of Chinese patients newly diagnosed with gastrointestinal cancer. Cancer Nurs. 2004;27(5):389-99. 151. Miaskowski C. Gender differences in pain, fatigue, and depression in patients with cancer. JNCI Monographs. 2004;2004(32):139-43. 152. Robichaud M, Dugas MJ, Conway M. Gender differences in worry and associated cognitive-behavioral variables. J Anxiety Disord. 2003;17(5):501-16. 98

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APPENDIX

Appendix 1

Reg.nr

2010 Lungeoperasjonsstudien Rehabilitering etter lungeoperasjon

Pasientens navn: ____________________________________________

2010 Lungeoperasjonsstudien

2010 Lungeoperasjonsstudien Inklusjon

CRF 1

Sykehus:

Reg.nr

OUS - Rikshospitalet

OUS - Ullevål

St. Olav

Haukeland

Skriv tydelig med store bokstaver (evt lim: Fornavn

:…………………………………………………………………………………

Etternavn : ………………………………………………………………………………... Adresse

: ………………………………………………………………………………...

Postnr

: .....................

Sted: …………………………………………………

Telefonnummer: Fødselsdato: dag

Kjønn:

Mann

måned

år

Kvinne

Inklusjonskriterier

Kontrollert:

1. Menn og kvinner over 18 år

Ja

Nei Informert samtykke mottatt

Ja

Nei

2. Mistanke om lungekreft

Ja

Nei Spørreskjema mottatt

Ja

Nei

3. Ingen kognitive forstyrrelser

Ja

Nei Registrering nr. mottatt

Ja

Nei

4. Kunne lese og skrive norsk

Ja

Nei

Fyll ut skjema, send melding til Trine på tlf: 91774995 for tildeling av registreringsnummer. Skriv dette øverst i høyre hjørne (også på spørreskjema). Samle alle skjemaene i en konvolutt og oppbevar på avtalt sted.

…………………………………… dag

måned

år

signatur 2010 Lungeoperasjonsstudien

CRF 2 Røyking :

Nei ,ikke lenger

Ja

Fra år:

Nei

Til år:

Ca antall sigaretter pr dag (en sigarett tilsvarer ca 1 gram tobakk):

Hvordan ble sykdommen oppdaget: 1. Pasienten hadde symptomer

Ja

Nei

2. Røntgen thorax tatt i utredning av annen sykdom

Ja

Nei

3. Screening

Ja

Nei

Kliniske funn og undersøkelser preoperativt: Høyde:

cm

Vekt:

kg

FEV1:

,

liter

FVC:

,

liter

Medisiner preoperativt: Psykofarmaka

Hvilke……………………………………..

Smertestillende medikament:

Hvilke……………………………………..

Steroid inhalasjon (Pulmicort/ Flutide) Beta-2-agonist inhalasjon (Ventoline/ Bricanyl/ Oxis/ Serevent) Anticholinergica inhalasjon (Spiriva/ Atrovent /Ipraxa) Kombipreparat inhalasjon (Symbicort/ Seretid) Steroid tabletter (Prednisolon)

Tumortype: Adenokarsinom Plateepitelkarsinom Storcellet Ikke småcellet Annet…………………………………………

2010 Lungeoperasjonsstudien

TNM klassifikasjon (fra patolog): T: N: M:

Operasjonsdag:

.

.

Operasjonstype: Lobektomi Bilobektomi Pneumonektomi (pulmektomi) Kilereseksjon/ Wedge Annet: …………………………………………

Postoperativt: Antall døgn med dren:

dager

Antibiotika skiftet:

Ja

Nei

Reoperajon:

Ja

Nei

CRP først fallt, deretter steget:

Ja

Nei

Andre komplikasjoner: …………………………………………

Pasienten overflyttet til annet sykehus postoperativt:

Ja

Nei

Sykehus pasienten ble overflyttet til: ................................................................

2010 Lungeoperasjonsstudien

Appendix 2

Inklusjon Inklusjon: Nå dere skal inkludere pasienten finner dere først fram inklusjonsmappe. Ta med ”informert samtykke” forteller deretter pasienten litt om studien. Det er viktig å sjekke om pasienten har hørt at det er mistanke om kreft før du gir pasienten arket med ”Informert samtykke”. Dersom pasienten ikke vil være med i studien noteres dette på ark. Det skal noteres kjønn, alder og evt. årsak – dersom pasienten oppgir dette. Dersom pasienten ikke oppgir årsak skal dere ikke spørre om dette. Dersom pasienten vil være med i studien skal han og du underskrive på ”Informert samtykke”. Der det står rolle i studien skal dere skrive prosjektmedarbeider. Etter dere begge har underskrevet tas kopi av informert samtykke og levere dette til pasienten sammen med spørreskjema. Det er viktig å gjøre pasienten oppmerksom på at på side 9 i spørreskjema (der en spør om smerte)- at dersom vedkommende ikke har smerter så skal han hoppe til side 12 i skjema. Sykepleier må nå fylle ut første side i CRF skjema (CRF 1). Det kan enten skrive for hånd eller ta en merkelapp med pasientopplysninger. Etterpå sender sykepleier en tekstmelding eller ringe til meg for å få inklusjonsnummer og skrive dette på alle dokumentene. Skriv opp hva dere har gjort på inklusjons sjekklisten. Dersom dere lurer på noe må dere gjerne ringe meg enten på telefon nummer: 91774995 eller mobil 91173965.

Samtale ved inklusjon (Viktig å finne et sted som man kan være i fred, jeg sitter meg alltid ned). Bør bare ta med samtykket når du går inn første gangen og ikke de andre papirene. Hei mitt navn ……. Årsaken til at jeg kommer og snakker med deg nå er at vi holder på med en studie (på avdelingen/ sykehuset). Bakgrunnen for studien er at vi vet lite om hvordan pasienter som blir operert i lungene har det etter operasjonen. Dette gjør det vanskelig å forberede pasientene på hva som venter etter operasjonen. Dersom det er noe mange er plaget med kan vi kanskje gjøre noe for å forebygge dette. For å finne ut mer om hvordan pasientene har det har vi startet opp en studie som vi nå ber deg om å delta i. Studien innebærer for deg at du må svare på noen spørreskjema i tiden etter operasjonen. For å finne ut hvilke plager som du har hatt lenge og hvilke som evt. kommer etter operasjonen må du fylle ut første spørreskjema før operasjonen. Du trenger ikke gjøre det med en gang, men må gjøre det i løp av dagen. Her er litt informasjon om studien (levere samtykket) som du kan lese før du bestemmer deg for om du vil delta. Deltagelse i studien er frivillig og du vil få samme behandling selv om du ikke deltar. Til slutt: Takk for hjelpen og lykke til med operasjonen. Vanlige spørsmål: -

Tidsbruk til utfylling av spørreskjema? Dette er ca ½ time, varierer litt fra pasient til pasient.

-

Hvor mange spørreskjema må besvares? Til sammen 5, ett før operasjon. Deretter etter 1,5,9 og 12 måneder. Grunnen til mellomrommet mellom 1 og 5 måneder er at en del pasienter får cellegift da.

-

Hva skal spørreskjema brukes til? Resultatene vil bli publisert i nasjonale og internasjonale tidsskrift. Det er en sykepleier som skal ta doktorgrad på resultatene (noen pasienter synes det er veldig spennende)

-

Hvem er med i studien? Oslo Universitetssykehus – Rikshospitalet og Ullevål og St Olavs hospital er med i studien. Studien er finansiert av kreftforeningen.

"QQFOEJY


Forespørsel om deltakelse i forskningsprosjektet ”Rehabilitering etter lungeoperasjon” Bakgrunn og hensikt Dette er en forespørsel til deg som skal opereres med mistanke om lungekreft, om å delta i en studie for å få mer kunnskap om hvordan du opplever det første året etter operasjon. Studien vil kartlegge hvilke symptomer og plager pasienten kan oppleve, hvordan symptomer opptrer sammen og hvordan symptomene forandrer seg over tid. Studien vil også kartlegge hvilken støtte pasienten får etter operasjonen. Ved å få mer kunnskap om dette håper vi å kunne tilby bedre støtte og behandling til pasienter etter lungekreftoperasjon. Studien gjennomføres av Senter for Pasientmedvirkning og Sykepleieforskning ved Oslo Universitetssykehus, i samarbeid med Hjerte-, lunge og karklinikken ved OUS, Lungeavdelingen ved Haukeland Universitetssykehus samt Thoraxkirurgisk avdeling ved St Olavs Hospital. Hva innebærer studien? Alle som deltar i studien vil bli bedt om å fylle ut spørreskjema for å kartlegge ulike symptomer som smerte, tung pust, hoste tretthet (fatigue), søvnforstyrrelser, ernæringsproblemer, livskvalitet, angst og depresjon. Du vil også bli spurt om evt. andre sykdommer, helsetilstand, funksjonsstatus og hvilken sosial støtte du har fått etter operasjonen. For å kartlegge evt. endringer av symptomer over tid ønsker vi å følge deg i et år. Dette innbærer at du først fyller ut spørreskjema rett før operasjonen, deretter vil du få tilsendt skjema etter en, fem, ni og tolv måneder. Vi vil evt. ringe deg og minne deg på utfylling av skjemaene. Dersom du trenger hjelp til utfylling av skjema vil undertegnede være tilgjengelig på telefon. Det vil ta i underkant av en time og fylle ut spørreskjemaene. Noen av de som samtykker i å delta studien vil bli forespurt om å bli intervjuet muntlig om hvordan de opplevde det å bli overflyttet til lokalsykehus og om hvordan det har vært og komme hjem. Intervjuene vil enten bli gjort hjemme hos deg eller hvis du ønsker det på et sykehus i nærheten av der du bor. Intervjuene vil bli tatt opp på bånd og deretter bli skrevet ut. Det er fult mulig å si nei til deltagelse i denne delen av prosjektet selv om du deltar i resten av studien. Mulige fordeler og ulemper Studien medfører ingen kostnader og det er ingen risiko forbundet med studien. Du vil kanskje oppleve det som slitsomt eller belastende å svare på noen av spørsmålene i spørreskjemaet. Vi vil bistå deg med hjelp til utfylling av skjemaer dersom du ønsker det, og du kan bruke så lang tid du ønsker på utfyllingen. Hva skjer med informasjonen om deg? Informasjonen som registreres om deg skal kun brukes slik som beskrevet i hensikten med studien. Alle opplysningene vil bli behandlet uten navn og fødselsnummer eller andre direkte gjenkjennende opplysninger. Evt. lydbånd som er tatt opp vil bli slettet etter intervjuet er skrevet ut. En kode, som vil være unik for hver deltager i studien, vil knytte deltagerne til opplysninger. Listen som sammenkobler koden og personnummer, oppbevares innelåst i et skap, fysisk atskilt fra svarene på spørreskjemaene. Det er kun autorisert personell knyttet til prosjektet som har adgang til navnelisten og som kan finne tilbake til deg. Vi regner med at studien i si helhet vil avsluttes i 2014, og at listen med koder vil slettes senest 5 år etter studien er avsluttet. Som en del av studien ønsker vi informasjon om din sykdom, tilleggssykdommer og medisiner du står på fra din journal på sykehuset. Du vil ha rett til å ha innsyn i hvilke opplysninger som er registrert,

samt til å kreve retting av feilaktige opplysninger. Vi ønsker også å registrere opplysninger om alder, kjønn, diagnose og operasjonstype på dersom du sier nei til å delta i studien. Oslo Universitetssykehus ved administrerende direktør er dataansvarlig for studien. Studien er godkjent av Regional Etisk Komité Sør-Øst Norge og Personvernombudet ved Oslo Universitetssykehus, avdeling Rikshospitalet. Det vil ikke være mulig å identifisere deg i resultatene av studien når disse publiseres Frivillig deltakelse Det er frivillig å delta i studien. Du kan når som helst og uten å oppgi noen grunn trekke ditt samtykke til å delta i studien uten at dette vil få konsekvenser for din videre behandling. Dersom du ønsker å delta, undertegner du samtykkeerklæringen på siste side. Om du nå sier ja til å delta, kan du senere trekke tilbake ditt samtykke uten at det påvirker din øvrige behandling. Du kan kreve at innsamlet data blir slettet. Data som allerede er analysert og publisert kan ikke trekkes tilbake. Dersom du senere ønsker å trekke deg eller har spørsmål til studien, kan du kontakte sykepleier og doktorgradsstipendiat Trine Oksholm ([email protected], tlf: 23075437, eller mobil: 91173965), eller prosjektleder Tone Rustøen ([email protected], tlf: 23075462).

Med vennlig hilsen

Tone Rustøen (sykepleier og professor)

Johny Kongerud (seksjonsoverlege og forsker)

Trine Oksholm (sykepleier og stipendiat)

Samtykke til deltakelse i studien Jeg er villig til å delta i studien ---------------------------------------------------------------------------------------------------------------(Signert av prosjektdeltaker, dato)

Jeg bekrefter å ha gitt informasjon om studien ---------------------------------------------------------------------------------------------------------------(Signert, rolle i studien, dato)

Registreringsnummer

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Lungeopererte ”Vi vil vite hvordan du har det”

Spørreskjema til deltagere i studien Dette er første spørreskjema til deg som har samtykket i å delta studien i studien. Du kan oppleve at noen av spørsmålene overlapper hverandre. Grunnen til dette er at vi bruker standardiserte skjemaer som gjør det mulig å sammenligne resultatene fra denne studien med andre studier. Vi ber deg svare på alle spørsmålene selv om du synes noen av dem ikke passer helt til deg. Mange takk

Baseline

Registreringsnummer

Reg. nr.:

Draft

SYMPTOMLISTE (MSAS)

Veiledning: Vi har listet opp 32 symptomer nedenfor. Les hvert av dem nøye. Hvis du har hatt symptomet i løpet av siste uken, la oss få vite hvor ofte du hadde det, hvor kraftig det var det meste av tiden, og hvor mye det plaget eller bekymret deg, ved å sette ett kryss i den ruten du synes passer best. Hvis du IKKE HAR HATT symptomet, sett ett kryss i den ruten merket HAR IKKE HATT symptomet. Hvis JA: Hvor kraftig var symptomet, det meste av tiden?

Hvis JA: Hvor ofte hadde du symptomet?

Hvis JA: Hvor mye plaget eller bekymret symptomet deg?

Svært mye

Ganske mye

En del

Litt

Ikke i det hele tatt

Svært kraftig

Kraftig

Moderat

Svakt

Nesten hele tiden

Ofte

Av og til

Sjelden

Har du hatt noen av de følgende symptomene?

Har ikke hatt symptomet

I løpet av den siste uken:

Vanskelig å konsentrere seg Smerter Har lite energi Hoste Føler meg nervøs Tørr i munnen Kvalme Søvnig, mye trøtt Nummen / prikker i hender / føtter Søvnvansker Luft i magen / oppblåst Problemer med vannlating Kaster opp Kortpustet Diaré Føler meg trist Svette Bekymrer meg Problemer med seksuallyst / aktivitet XX Studien

1/2

Kontor for klinisk forskning, Rikshospitalet HF

2

Lungeoperasjon studien

Reg. nr.:

Draft

SYMPTOMLISTE (MSAS) - del 2 Hvis JA: Hvor ofte hadde du symptomet?

Hvis JA: Hvor kraftig var symptomet, det meste av tiden?

Hvis JA: Hvor mye plaget eller bekymret symptomet deg?

Ikke i det hele tatt

Litt

En del

Ganske mye

Svært mye

Ikke i det hele tatt

Litt

En del

Ganske mye

Svært mye

Svært kraftig

Kraftig

Moderat

Svakt

Nesten hele tiden

Ofte

Av og til

Sjelden

Har du hatt noen av de følgende symptomene?

Har ikke hatt symptomet

I løpet av den siste uken:

Kløe Manglende matlyst Svimmel / ør Vanskelig å svelge Føler meg irritabel Sår i munnen Maten smaker annerledes Vekttap Mistet håret Treg mage / forstoppelse Hoven i armer og ben "Jeg ser ikke ut som meg selv lengre" Forandringer i huden Hvis du har hatt noen andre symptomer i løpet av den siste uken, vennligst skriv de opp nedenfor, og angi hvor mye det plaget eller bekymret deg. Annet:

Annet:

Annet: XX Studien

2/2

3

Kontor for klinisk forskning, Rikshospitalet HF

Lungeoperasjon studien

Draft

Livskvalitetsskjema (EORTC)

Vi er interessert i forhold vedrørende deg og din helse. Vær vennlig å besvare hvert spørsmål ved å sette et kryss x i den boksen som best beskriver din tilstand. Det er ingen "riktige" eller "gale" svar.

1.

Har du vanskeligheter med å utføre anstrengende aktiviteter, slik som å bære en tung handlekurv eller en koffert?

2.

Har du vanskeligheter med å gå en lang tur?

3.

Har du vanskeligheter med å gå en kort tur utendørs?

4.

Er du nødt til å ligge til sengs eller sitte i en stol i løpet av dagen?

5.

Trenger du hjelp til å spise, kle på deg, vaske deg eller gå på toalettet?

I løpet av den siste uka:

6.

Har du hatt redusert evne til å arbeide eller utføre andre daglige aktiviteter?

7.

Har du hatt redusert evne til å utføre dine hobbyer eller andre fritidsaktiviteter?

8.

Har du vært tung i pusten?

9.

Har du hatt smerter?

10.

Ikke i det hele tatt

Litt

En del

Svært mye

Ikke i det hele tatt

Litt

En del

Svært mye

Har du hatt behov for å hvile?

11. Har du hatt søvnproblemer? 12.

Har du følt deg slapp?

13.

Har du hatt dårlig matlyst?

14.

Har du vært kvalm?

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Lungeoperasjon studien

Draft

Ikke i det hele tatt

I løpet av den siste uka:

15.

Har du kastet opp?

16.

Har du hatt treg mage?

17.

Har du hatt løs mage?

18.

Har du følt deg trett?

19.

Har smerter påvirket dine daglige aktiviteter?

20.

Har du hatt problemer med å konsentrere deg, f.eks. med å lese en avis eller se på TV?

21.

Har du følt deg anspent?

22.

Har du vært engstelig?

23.

Har du følt deg irritabel?

24.

Har du følt deg deprimert?

25.

Har du hatt problemer med å huske ting?

26.

Har din fysiske tilstand eller medisinske behandling påvirket ditt familieliv?

27.

Har din fysiske tilstand eller medisinske behandling påvirket dine sosiale aktiviteter?

28.

Har din fysiske tilstand eller medisinske behandling gitt deg økonomiske problemer?

Litt

Svært mye

En del

Som svar på de neste spørsmålene, sett et kryss i den ruten som best beskriver din tilstand.

29.

Hvordan har din helse vært i løpet av den siste uka? 1

2

3

4

5

6

Svært dårlig

30.

7 Helt utmerket

Hvordan har livskvaliteten din vært i løpet av den siste uka? 1

2

3

4

Svært dårlig

5

6

7 Helt utmerket

5

Lungeoperasjon studien

NORWEGIAN



EORTC QLQ - LC13 Endel pasienter opplever av og til at har noen av følgende symptomer eller problemer. Vær vennlig å angi i hvilken grad du har hatt disse symptomene eller problemene i løpet av den siste uka. Sett en ring rundt det tallet som best beskriver din tilstand. ____________________________________________________________________________________

I løpet av den siste uka:

Ikke I det hele tatt

Litt

Endel

Svært mye

31. Hvor mye har du hostet ?

1

2

3

4

32. Har du hostet blod ?

1

2

3

4

33. Har du vært tungpustet i hvile ?

1

2

3

4

34. Har du vært tungpustet når du har gått ?

1

2

3

4

35. Har du vært tungpustet når du har gått i trapper ?

1

2

3

4

36. Har du vært sår i munnen eller på tungen ?

1

2

3

4

37. Har du hatt svelgproblemer ?

1

2

3

4

38. Har du hatt prikkinget (stikninger) i hendene eller i bena ?

1

2

3

4

39. Har du hatt håravfall ?

1

2

3

4

40. Har du hatt smerter i brystet ?

1

2

3

4

41. Har du hatt smerter i arm eller skulder ?

1

2

3

4

42. Har du hatt smerter i andre deler av kroppen ?

1

2

3

4

1

2

3

4

Hvis ja, hvor har du hatt vondt ? ______________________ 43. Har du brukt smertestillende medisiner ? 1. Nei

2. Ja

Hvis Ja, hvor mye har det hjulpet ?

© QLQ-C30-LC13 Copyright 1994 EORTC Study Group on Quality of life. All rights reserved 6

Lungeoperasjon studien

Draft

TILLEGGSSYKDOMMER (SCQ-18) Det følgende er en liste over vanlige medisinske problemer. Sett ett kryss for hvert problem om hvorvidt du har problemet nå (ja eller nei). Hvis du HAR problemet, så svar på spørsmålene om behandling og aktiviteter til høyre. Hvis du IKKE HAR problemet, gå videre til neste problem. Har du problemet?

HVIS JA: Får du behandling for det?

HVIS JA: Begrenser det dine aktiviteter?

1. Hjertesykdom

Ja

Nei

Ja

Nei

Ja

Nei

2. Høyt blodtrykk

Ja

Nei

Ja

Nei

Ja

Nei

3. Andre lungesykd. (KOLS)

Ja

Nei

Ja

Nei

Ja

Nei

4. Diabetes

Ja

Nei

Ja

Nei

Ja

Nei

5. Magesår/magesykdom

Ja

Nei

Ja

Nei

Ja

Nei

6. Tarmsykdom

Ja

Nei

Ja

Nei

Ja

Nei

7. Nyresykdom

Ja

Nei

Ja

Nei

Ja

Nei

8. Leversykdom

Ja

Nei

Ja

Nei

Ja

Nei

9. Anemi eller annen blodsykdom

Ja

Nei

Ja

Nei

Ja

Nei

10. Hodepine

Ja

Nei

Ja

Nei

Ja

Nei

11. Depresjon

Ja

Nei

Ja

Nei

Ja

Nei

12. Slitasjegikt/artrose

Ja

Nei

Ja

Nei

Ja

Nei

13. Rygg/nakkesmerter

Ja

Nei

Ja

Nei

Ja

Nei

14. Leddgikt/revmatoid artritt

Ja

Nei

Ja

Nei

Ja

Nei

15. Sykdom i bindevev eller muskulatur

Ja

Nei

Ja

Nei

Ja

Nei

16. Hudlidelser

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

Ja

Nei

17. Andre medisinske problemer (angi)

15

Lungeoperasjon studien

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Rehabilitering etter lungeoperasjon

Kjære deltager i studien Nå har det gått 1 måned siden du ble med i denne studien og fylte ut spørreskjema på sykehuset før lungeoperasjonen. Hensikten med studien er å få mer kunnskap om hvordan pasientene har det i tiden etter de operert. Som avtalt sender vi deg nå spørreskjema til utfylling samt en frankert konvolutt som du kan bruke til å sende skjemaene tilbake til oss. Vi håper du kan fylle det ut så snart som mulig. Dersom du glemmer å sende skjema tilbake vil vi sende et deg et påminningsbrev om et par uker. Deltagelse i studien er frivillig. Dersom du har spørsmål om selve studien eller det er noe uklart med spørsmålene kan du ringe sykepleier og stipendiat Trine Oksholm ved Senter for pasientmedvirkning og sykepleieforskning på mobiltelefon: 917 74 995 eller eventuelt e-post: [email protected].

Med vennlig hilsen Tone Rustøen (sykepleier og professor)

Johny Kongerud (seksjonsoverlege og forsker)

Trine Oksholm (sykepleier og stipendiat)

"QQFOEJY


Da inviterer vi deg til å delta i en studie.

Skal du opereres i lungen?

Hei.

Vi vet lite om hvordan pasienter som er operert i lungene har det i månedene etter at de er operert. For å få vite mer om dette har vi startet opp en studie. Hensikten med studien er å få mer kunnskap slik at helsepersonell bedre kan informere pasientene om hvilke problemer som kan oppstå etter operasjonen. Studien gjennomføres i samarbeid mellom Oslo Universitetssykehus, Rikshospitalet og Ullevål og St Olavs hospital i Trondheim.

Bakgrunn for studien

Studien undersøker hvordan pasienter som er operert i lungene har det etter operasjonen. Denne kunnskapen kan komme pasientene til gode på lengre sikt.

Trine Oksholm sykepleier og stipendiat E-post: [email protected] Telefon : 91774995.

Har du spørsmål vedrørende studien, kan du kontakte meg:

Du har mulighet til å bli med i studien når du innlegges på sykehus før operasjonen. En sykepleier vil komme og spørre deg om du kan tenke deg å delta. Deltagelse i studien er frivillig. Dersom du sier nei vil det ikke påvirke behandlingen du får.

Hvordan er det mulig å delta?

Alle som deltar i studien vil bli bedt om å fylle ut spørreskjema om ulike symptomer, livskvalitet og sosial støtte. For å kartlegge evt. endringer av symptomer over tid ønsker vi å følge deg i et år. For å vite hvilke symptomer og plager du evt. har fra før ber vi deg om å fylle ut spørreskjema før operasjonen. Skjema trengs ikke å fylles ut med en gang, bare du er ferdig før du skal opereres. De andre skjemaene vil du få tilsendt i posten etter en, fem, ni og tolv måneder. Dersom du trenger hjelp til utfylling av skjema kan vi hjelpe deg med dette. Det tar vanligvis i underkant av en halv time og fylle ut spørreskjemaet.

Hva innebærer studien?